DB-1303/BNT323 Clinical Trials (2026): 5 Studies for Metastatic Breast Cancer & Endometrial Cancer
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
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5 DB-1303/BNT323 clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 5 indications (including Metastatic Breast Cancer & Endometrial Cancer) and 2,425 total planned enrollment. 3 Phase 3 DB-1303/BNT323 trials are listed. 3 DB-1303/BNT323 clinical trials are actively recruiting at 17 U.S. sites across 12 states. Most recent activity: NCT06340568 (Nov 2029).
Where to Participate: All DB-1303/BNT323 Trial Sites in the U.S. (17 sites across 12 states)
Every actively recruiting DB-1303/BNT323trial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| CA | Beverly Hills Cancer Center | Beverly Hills90211 | NCT06827236 | Map |
| DC | MedStar Washington Hospital Center | Washington D.C.20010 | NCT06340568 | Map |
| FL | Broward Health Medical Center | Fort Lauderdale33316 | NCT06340568 | Map |
| FL | Hematology - Oncology Associates of the Treasure Coast | Port Saint Lucie34952 | NCT06827236 | Map |
| GA | University Cancer & Blood Center, LLC | Athens30607 | NCT06827236 | Map |
| GA | Winship Cancer Institute of Emory University | Atlanta30322 | NCT06827236 | Map |
| MI | START Midwest, LLC | Grand Rapids49546 | NCT06827236 | Map |
| MO | Saint Luke's Hospital of Kansas City | Kansas City64111 | NCT06827236 | Map |
| MO | Washington University School of Medicine | St Louis63110 | NCT06827236 | Map |
| NV | The Center of Hope Reno | Reno89511 | NCT06340568 | Map |
| NJ | Summit Medical Group | Florham Park07932 | NCT06827236 | Map |
| NY | Memorial Sloan Kettering Hospital | New York10065 | NCT06827236 | Map |
| NY | NYU Langone Health | New York10016 | NCT06340568 | Map |
| OH | Miami Valley Hospital South | Centerville45459 | NCT06340568 | Map |
| OH | Ohio State University | Hilliard43026 | NCT06340568 | Map |
| SD | Sanford Cancer Center | Sioux Falls57104 | NCT06340568 | Map |
| TX | South Texas Accelerated Research Therapeutics (START), LLC | San Antonio78229 | NCT06827236 | Map |
DB-1303/BNT323 clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | Total |
|---|---|---|---|
| P1/P2 | 2 | 2 | |
| P3 | 1 | 2 | 3 |
Recruiting DB-1303/BNT323 clinical trials (3)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06340568 | Fern-EC-01A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer | P3 | Endometrial Cancer | 480 | Jun 2025 |
| NCT06827236 | A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer | P1/P2 | Locally Advanced Breast Cancer | 380 | Apr 2025 |
| NCT05150691 | A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors | P1/P2 | HER2-positive Advanced Solid Tumor | 796 | Jan 2022 |
DB-1303/BNT323 clinical trials by indication
Endometrial Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06340568 | Fern-EC-01 | P3 | recruiting | A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer |
Locally Advanced Breast Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06827236 | — | P1/P2 | recruiting | A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer |
HER2-positive Breast Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06265428 | — | P3 | active not recruiting | A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer |
Metastatic Breast Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06018337 | — | P3 | active not recruiting | A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) |
HER2-positive Advanced Solid Tumor (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05150691 | — | P1/P2 | recruiting | A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors |
DB-1303/BNT323 pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| Fern-EC-01 | NCT06340568 | P3 | recruiting | Endometrial Cancer | 480 | PMID 40966692 |
All DB-1303/BNT323 trials (5)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06340568 | Fern-EC-01 | A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer | P3 | recruiting | 480 | BioNTech SE | Jun 2025 |
| NCT06827236 | A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer | P1/P2 | recruiting | 380 | BioNTech SE | Apr 2025 | |
| NCT06018337 | A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02) | P3 | active not recruiting | 541 | DualityBio Inc. | Jan 2024 | |
| NCT05150691 | A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors | P1/P2 | recruiting | 796 | DualityBio Inc. | Jan 2022 | |
| NCT06265428 | A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer | P3 | active not recruiting | 228 | DualityBio Inc. | Jan 2024 |
DB-1303/BNT323 clinical trials: frequently asked questions
- How many DB-1303/BNT323 clinical trials are there?
- 5 DB-1303/BNT323 clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 3 are actively recruiting participants.
- Are DB-1303/BNT323 clinical trials recruiting in 2026?
- Yes — 3 DB-1303/BNT323 trials are actively recruiting in 2026, with 17 U.S. sites across 12 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is DB-1303/BNT323 being studied for?
- DB-1303/BNT323 is being studied for Metastatic Breast Cancer, Endometrial Cancer, HER2-positive Advanced Solid Tumor, HER2-positive Breast Cancer, Locally Advanced Breast Cancer and 1 more. The trials are grouped by indication on this page.
- What phase is DB-1303/BNT323 in?
- DB-1303/BNT323 clinical trials span 3 Phase 3. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors DB-1303/BNT323 clinical trials?
- The lead sponsor across the most DB-1303/BNT323 trials is DualityBio Inc., with 1 additional lead sponsor listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming DB-1303/BNT323as an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
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